Study Manager (97278)
Minimum requirements:
Additional skills:
(1) Strong background in managing clinical trials in a matrix-structured organization
(2) Process development and background in overseeing process implementation
(3) Strong site monitoring experience
(4) Intimate understanding of Microsoft Office including excel and project plans
(5) Comfortable engaging physicians in the context of clinical trials
Job Description:
Assumes primary clinical study management responsibilities and actively participates on cross-functional project teams responsible for the development and scientific research of primary staining, advanced staining and digital pathology products. Study leadership in all aspects of cross functional relationships in order to create a cooperative work environment in support of corporate goals.
Essential Functions:
- Manages day-to-day activities of all aspects of clinical studies for assigned projects, including study plans, monitoring plans (as appropriate), timelines, resources, problem identification and resolution, status reports and budgets to ensure timely delivery of completed study deliverables.
- Assists in the development of supported and sponsored studies, including the development of protocols, informed consent documents (as appropriate), case report forms (CRFs), and data collection and review.
- In conjunction with procurement, coordinates the request for information and request for proposal processes, including site feasibility and qualification assessments.
- Oversees the site approval, start-up, maintenance, and close-out processes with respect to contract review, critical document and reporting requirements and ICH/GCP, in conjunction with project team.
- Identifies and evaluates study and project issues, and issue escalation oversight; oversees all safety reporting, documentation and follow-up.
- Provides oversight and direction to project team members and study staff for study deliverables; including training as needed.
- Represents Medical Affairs as the study subject matter expert in Lifecycle or external joint project team meetings.
- Manages the development and implementation of improved processes for execution of internal and external studies within the COMPANY Quality System.
- May assist in the management of independent consultants including CROs, clinicians, independent CRAs, or statisticians when required by the project including selection, coordination of project specific training, and payment.
- Monitors work to ensure quality, and continuously promote Quality First Time.
MINIMUM
Qualifications:
Formal Training/Education:
- Bachelor of Science, or RN or BSN; OR equivalent combination of education and clinical research.
Experience:
- Minimum 5
years of clinical research experience including clinical/laboratory site monitoring OR 3
years of clinical research experience with in vitro diagnostic assays (IVDs).
- Extensive and varied clinical and laboratory monitoring experience.
- Previous industry experience highly preferred.
- Background in molecular biology/biochemistry, laboratory experience or nursing experience preferred.
Knowledge, Skills, and Abilities:
- Proven study management skills and study leadership abilities.
- Extensive knowledge of US FDA CFR and guidelines applicable to conducting trials involving humans or specimens from humans and investigational in-vitro diagnostic devices to be marketed in the US.
- Knowledge of international directives including those applicable to the conduct of trials involving humans or specimens from humans and in-vitro diagnostic devices to be marketed outside the US.
- Interpersonal skills including problem recognition and solving ability.
- Ability to promote and lead teamwork in a cross-functional, dynamic, matrix organization.
- Ability to gain and share knowledge regarding changing therapeutic areas.
- Excellent verbal communication and writing skills.
- Ability to create and deliver presentations to experts in cancer research, diagnostic and medical therapies.
- Ability to travel, as needed.
- Computer and administrative skills (Word, Excel, Access, PowerPoint and Microsoft Project) and understanding of project management processes.
Estimated Salary: $20 to $28 per hour based on qualifications.
Additional skills:
(1) Strong background in managing clinical trials in a matrix-structured organization
(2) Process development and background in overseeing process implementation
(3) Strong site monitoring experience
(4) Intimate understanding of Microsoft Office including excel and project plans
(5) Comfortable engaging physicians in the context of clinical trials
Job Description:
Assumes primary clinical study management responsibilities and actively participates on cross-functional project teams responsible for the development and scientific research of primary staining, advanced staining and digital pathology products. Study leadership in all aspects of cross functional relationships in order to create a cooperative work environment in support of corporate goals.
Essential Functions:
- Manages day-to-day activities of all aspects of clinical studies for assigned projects, including study plans, monitoring plans (as appropriate), timelines, resources, problem identification and resolution, status reports and budgets to ensure timely delivery of completed study deliverables.
- Assists in the development of supported and sponsored studies, including the development of protocols, informed consent documents (as appropriate), case report forms (CRFs), and data collection and review.
- In conjunction with procurement, coordinates the request for information and request for proposal processes, including site feasibility and qualification assessments.
- Oversees the site approval, start-up, maintenance, and close-out processes with respect to contract review, critical document and reporting requirements and ICH/GCP, in conjunction with project team.
- Identifies and evaluates study and project issues, and issue escalation oversight; oversees all safety reporting, documentation and follow-up.
- Provides oversight and direction to project team members and study staff for study deliverables; including training as needed.
- Represents Medical Affairs as the study subject matter expert in Lifecycle or external joint project team meetings.
- Manages the development and implementation of improved processes for execution of internal and external studies within the COMPANY Quality System.
- May assist in the management of independent consultants including CROs, clinicians, independent CRAs, or statisticians when required by the project including selection, coordination of project specific training, and payment.
- Monitors work to ensure quality, and continuously promote Quality First Time.
MINIMUM
Qualifications:
Formal Training/Education:
- Bachelor of Science, or RN or BSN; OR equivalent combination of education and clinical research.
Experience:
- Minimum 5
years of clinical research experience including clinical/laboratory site monitoring OR 3
years of clinical research experience with in vitro diagnostic assays (IVDs).
- Extensive and varied clinical and laboratory monitoring experience.
- Previous industry experience highly preferred.
- Background in molecular biology/biochemistry, laboratory experience or nursing experience preferred.
Knowledge, Skills, and Abilities:
- Proven study management skills and study leadership abilities.
- Extensive knowledge of US FDA CFR and guidelines applicable to conducting trials involving humans or specimens from humans and investigational in-vitro diagnostic devices to be marketed in the US.
- Knowledge of international directives including those applicable to the conduct of trials involving humans or specimens from humans and in-vitro diagnostic devices to be marketed outside the US.
- Interpersonal skills including problem recognition and solving ability.
- Ability to promote and lead teamwork in a cross-functional, dynamic, matrix organization.
- Ability to gain and share knowledge regarding changing therapeutic areas.
- Excellent verbal communication and writing skills.
- Ability to create and deliver presentations to experts in cancer research, diagnostic and medical therapies.
- Ability to travel, as needed.
- Computer and administrative skills (Word, Excel, Access, PowerPoint and Microsoft Project) and understanding of project management processes.
Estimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
